Kornimate/medical-research-clean huggingface dataset:
popliteal block for postoperative pain in knee-ankle soft tissue surgery in cerebral palsy

Conditions: Postoperative Pain; Cerebral Palsy

Summary: popliteal block is a technique for providing postoperative pain management in children. in this randomized double-blinded study, the investigators evaluated the effects of preoperative popliteal nerve block on postoperative pain and analgesic requirement in children with cerebral palsy (cp) undergoing knee-anckle soft tissue surgery. the wong baker faces scale and skin conductance fluctuations will be assessed.

sevoflurane will be used for anesthesia induction and maintance. laryngeal mask airway will be placed without neuromuscular blocking agent. in group p (popliteal block), a single dose of 0.3ml.kg(-1) of 0.25% bupivacaine will be performed for popiteal nerve block (with ultrasound guidence). in group c ( control), only plaster cover will be applied without nerve block for sham procedure to provide double-blinded study. intraoperative heart rate, mean arterial pressure, bis (bispectral index) values, sevoflurane consumption will be recorded ten minutes interval. wong baker faces scale and skin conductance fluctuations will be recorded at postoperative 0, 10th min, 20th min , 1st h, 4th h, 12th h qnd 24th h. total analgesic consumption (paracetamol orally ) will be recorded.

Eligibility criteria:
inclusion criteria: * children with cerebral palsy * scheduled for knee and ankle surgery exclusion criteria: * autonomic neuropathy * medication with anticholinergic drugs * continuous infusion of vasoactive drugs

Keywords: nerve block
prospective study to investigate the frequency of possible bacterial entry into the bloodstream (bacteremia) and infectious complications associated with the use of the spyglass cholangioscopy system during ercp (endoscopic retrograde cholangiopancreatography).

Conditions: Bile Duct Stricture; Choledocholithiasis

Summary: the aim of this study is to prospectively evaluate the frequency of bacteremia after ercp/cholangioscopy using the spyglass direct visualization system. in addition, the frequency of cholangitis/sepsis despite use of post procedural antibiotics will be studied.

rates of bacteremia (bacterial seeding of the blood) following ercp's range from 6.4% to 18.0%. however, infectious complications of cholangitis/sepsis occur in only 0.5%- 3.0% of patients undergoing this procedure. the spyglass direct visualization system allows cholangioscopy with direct visualization of the bile duct during ercp by using a specialized small caliber endoscope. during the spyglass portion of the procedure, saline is introduced into the bile duct to to irrigate the biliary system, in order to distend the biliary ducts and to improve visualization by clearing contrast, pus and stone debris. saline irrigation may increase intrabiliary pressures and may therefore theoretically increase the risk for bacteremia and infection. the effect of spyglass cholangioscopy and biliary irrigation on the frequency of bacteremia/post cholangioscopy infections is unknown and has not previously been studied. the aim of this study is to prospectively evaluate the frequency of bacteremia after ercp/cholangioscopy using the spyglass system.

Eligibility criteria:
inclusion criteria: 1. age 18-80 2. biliary disease such as large stones necessitating electrohydraulic lithotripsy; 3. biliary strictures needing tissue acquisition through cholangioscopic directed biopsies 4. pancreatic-biliary malignancies needing tissue acquisition through cholangioscopic directed biopsies 5. willing and able to comply with the study procedures and provide written informed consent to participate in the study. exclusion criteria: 1. age \ 80 2. potentially vulnerable subjects including pregnant women, homeless people, employees and students. 3. patients who have a clear indication for pre-procedure antibiotics based on current asge guidelines 4. patients who had received antibiotics for any reason within the prior 7 days 5. patients who had evidence of systemic infection at time of the ercp 6. patients in whom additional venous access for blood cultures cannot be established. 7. participation in another investigational study within the previous 90 days

Keywords: bacteremia spyglass cholangioscopy
clindamycin in prosthetic joint infections caused by staphylococcus (cista)

Conditions: Prosthetic Joint Infection; Staphylococcus

Summary: the alternatives to the combination of fluoroquinolone and rifampicin in prosthetic joint infections (pji) caused by staphylococcus are currently unclear. clindamycin is prescribed as dual therapy in this indication, and provides many advantages. we conducted a multicenter retrospective observational study evaluating the efficacy and safety of clindamycin in prosthetic joint infections due to staphylococcus between january 2013 and december 2019.


Eligibility criteria:
inclusion criteria: * patients with pji defined according to the idsa. * infection must be mono-microbial or multi-microbial with staphylococcus spp sensitive to clindamycin. * infection may be acute or chronic, nosocomial or community-acquired. * patient having received a curative treatment with clindamycin. exclusion criteria: * patients with osteitis, osteomyelitis, septic arthritis in native joints, diabetic foot infections, spondylodiscitis, infections in external fixator, surgical site infections following neurosurgical management, bedsores, skin and soft tissue infections. * patients with mono-microbial infections other than staphylococcus, multi-microbial infections including other bacteria than staphylococcus, suspected osteoarticular infection without microbial identification. * patients with clindamycin-resistant staphylococcal pji, constitutive mlsb phenotype. * patients having received suspensive treatment with clindamycin. * patients treated with clindamycin as last line of treatment for a duration of less than 14 days. * patients refusing to participate * patients under legal protection (guardianship, curatorship, ..)
pharmacokinetic evaluation of testosterone gel (1%)

Conditions: Primary or Secondary Hypogonadism; Constitutional Delay in Growth and Puberty (CDGP)

Summary: measure and evaluate the level of testosterone in blood, and determine the safety and tolerability following daily applications of testosterone gel. subjects who complete this trial may participate in the extension part (umd-01-080e).


Eligibility criteria:
inclusion criteria: * diagnosis of primary or secondary hypogonadism or constitutional delay in growth and puberty (cdgp) exclusion criteria: * clinically significant uncontrolled medical condition or psychiatric disorder

Keywords: hypogonadism
vaccine therapy for patients being considered for organ transplant who are at risk for ptld

Conditions: Lymphoproliferative Disorder

Summary: rationale: vaccines made from a person's white blood cells may help the body build an effective immune response. purpose: this phase i trial is studying the side effects of vaccine therapy in treating patients who are being considered for solid organ transplant who are at risk for post-transplant lymphoproliferative disorder.

objectives: primary * determine the efficacy of photochemically-treated autologous epstein-barr virus (ebv)-transformed b-lymphoblastoid cell vaccine in generating an ebv-specific t-cell and antibody response in ebv-negative patients or in boosting the response in ebv-positive patients who are being considered for a solid organ transplant and are at high risk for post-transplant lymphoproliferative disorder. * determine adverse events associated with this vaccine in these patients. * determine the ability of the vaccine to protect from ebv primary infection in ebv-seronegative patients during the time course of the study. outline: this is a nonrandomized, pilot study. patients are stratified according to epstein-barr virus (ebv) status (seropositive vs seronegative). patients receive photochemically-treated autologous ebv-transformed b-lymphoblastoid cell vaccine intradermally once in weeks 0 and 4. after completion of study treatment, patients are followed periodically for up to 5 years. projected accrual: a total of 40 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * being considered for a solid organ transplant * at high risk for post-transplant lymphoproliferative disorder patient characteristics: * body weight ≥ 25 kg * karnofsky performance status 50-100% or * lansky performance status 50-100% * not pregnant * negative pregnancy test * fertile patients must use contraception during and for 2 months after completion of study treatment * hemoglobin ≥ 8 g/dl (erythropoietin allowed) * no history of autoimmune disease, including any of the following: * systemic lupus erythematosus * sarcoidosis * rheumatoid arthritis * glomerulonephritis * vasculitis * no primary immunodeficiency * no hiv positivity prior concurrent therapy: * no corticosteroids for 1 month before and for 1 month after the first study vaccination, except for the following: * physiologic steroid dosing (≤ 20 mg/day of prednisone or steroid equivalent) for adrenal insufficiency * inhaled steroids

Keywords: post-transplant lymphoproliferative disorder
cinc424a2x01b rollover protocol

Conditions: Primary Myelofibrosis; Polycythemia Vera; Graft Versus Host Disease; Acute Myeloid Leukemia; Thalassemia

Summary: this is a long term safety study for patients that have been treated with either ruxolitinib or a combination of ruxolitinib with panobinostat, on a novartis or incyte sponsored study, who have been judged by the study investigator to benefit from ongoing treatment.

this roll-over protocol allows patients from multiple protocols, who are still receiving clinical benefit, to continue their treatment in one study that covers multiple indications. the population for the roll-over study should be consistent with the population defined in the parent studies. the primary eligibility criteria for a patient to enter the roll-over protocol is the participation and completion of a novartis or incyte study with ruxolitinib monotherapy or combination of ruxolitinib and panobinostat. efficacy parameters will not be measured; however safety data and an evaluation of clinical benefit will be collected.

Eligibility criteria:
key inclusion criteria: 1. patient is currently enrolled in a novartis gdd or gma-sponsored or incyte-sponsored clinical study, are receiving either ruxolitinib or combination of ruxolitinib and panobinostat, and fulfilled all of the requirements of the parent protocol. 2. patient is currently benefiting from the treatment with ruxolitinib monotherapy or combination of ruxolitinib and panobinostat, as determined by the investigator 3. patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements 4. patient currently has no evidence of progressive disease, as determined by the investigator, following previous treatment with ruxolitinib or combination of ruxolitinib and panobinostat key exclusion criteria: 1. patient has been permanently discontinued from study treatment in the parent study due to any reason. 2. patient's indication is currently approved and reimbursed in the corresponding country for ruxolitinib monotherapy or combination of ruxolitinib and panobinostat. 3. pregnant or nursing (lactating) women. 4. female patients of childbearing potential (e.g. are menstruating) who do not agree to abstinence or, if sexually active, do not agree to the use of highly effective contraception, throughout the study and for up to 30 days after stopping study treatment. other protocol-defined inclusion / exclusion criteria may apply.

Keywords: myelofibrosis mf polycythemia vera pv acute graft versus host disease agvhd chronic graft versus host disease cgvhd acute myeloid leukemia aml thalassemia ruxolitinib inc424 panobinostat lbh589
renal sympathectomy in treatment resistant essential hypertension, a sham controlled randomized trial

Conditions: Hypertension

Summary: the purpose of this double blind, randomized and sham controlled study is to determine whether renal denervation in terms of catheter based ablation in the renal arteries is effective in lowering blood pressure in patients with treatment resistant hypertension. the blood pressure lowering effect will be evaluated by 24 hours ambulatory blood pressure measurement at baseline and after 1, 3 and 6 months of follow up. secondary end point evaluation concerns hemodynamic measures using echocardiography, applanation tonometry and forearm plethysmography.


Eligibility criteria:
inclusion criteria: * systolic daytime ambulatory bp at least 145 mmhg and compliance to a minimum of 3 antihypertensive drugs, including a diuretic, or in case of diuretic intolerance at least 3 nondiuretic antihypertensive drugs. exclusion criteria: * pregnancy * non compliance * heart failure (nyha 3-4) * lv ejection fraction \< 50 % * renal insufficiency (egfr\<30) * unstable coronary heart disease * coronary intervention within 6 months * myocardial infarction within 6 months * claudication * orthostatic syncope within 6 months * secondary hypertension * permanent atrial fibrillation * significant heart valve disease * clinically significant abnormal electrolytes, haemoglobin, liver enzymes, tsh * second and third degree heart block * macroscopic haematuria * proximal significant coronary stenosis * renal artery anatomy not suitable for renal artery ablation (stenosis, small diameter \< 4 mm, length \< 2 cm, multiple renal arteries, severe calcifications)

Keywords: treatment resistant hypertension
effects of eszopiclone on sleep and memory in schizophrenia

Conditions: Schizophrenia

Summary: the investigators will test the hypothesis that the sleep medication, eszopiclone, can normalize brain activity during sleep and improve memory in patients with schizophrenia. the investigators will do this by measuring sleep and memory performance on two conditions separated by one week: taking 3 mg of eszopiclone and taking placebo. the investigators will study healthy subjects and chronic, medicated outpatients with schizophrenia.

sleep spindles, a defining oscillation of stage 2 non-rapid eye movement sleep (n2), are strongly linked to memory and iq in healthy individuals. schizophrenia is characterized by a spindle deficit that correlates with deficient sleep-dependent memory consolidation, symptom severity, iq and executive function. in a small pilot study of schizophrenia patients, eszopiclone , significantly increased sleep spindles but its effect on memory was not significant. here, in a larger double-blind, placebo-controlled, cross-over design study, we investigated whether eszopiclone can both increase spindle density and improve memory consolidation. chronic, medicated schizophrenia outpatients and demographically-matched healthy control participants were randomly assigned to receive either placebo first or 3mg of eszopiclone first for two consecutive nights with high density polysomnography. placebo and eszopiclone visits were one week apart. participants were trained on the motor sequence task (mst) at bedtime of the second night of each visit and tested the following morning to probe sleep-dependent motor memory consolidation.

Eligibility criteria:
inclusion criteria: * clinically stable outpatients with schizophrenia, * proficient in english, * able to give informed consent, * maintained on a stable dose of atypical antipsychotic medications for at least 6 weeks prior to enrollment. * healthy control participants matched as a group to the patients for age, sex, and parental socioeconomic status. exclusion criteria: * substance abuse or dependence within the past six months; * other chronic medical conditions that affect sleep; (- pregnancy/breast feeding; * hepatic impairment; * treatment with inhibitors or inducers of cyp 3a4 or 2e1 enzymes (which metabolize eszopiclone); * a history of head injury resulting in prolonged loss of consciousness or other neurological sequelae; (- mental retardation; (- a diagnosed sleep disorder other than insomnia, * neurological disorder; sleep disorder, other than insomnia, identified in a clinical sleep evaluation. patients on conventional agents, benzodiazepines, or other sleep agents will be excluded. potential controls will be excluded for a personal history of mental illness, a family history of schizophrenia spectrum disorder or psychosis, and treatment with medications known to affect sleep or cognition.

Keywords: sleep memory schizophrenia eszopiclone
angiotensinogen variants and adverse pregnancy outcomes

Conditions: Cardiovascular Diseases; Heart Diseases; Pre-Eclampsia

Summary: to examine angiotensinogen genetic variants and adverse pregnancy outcomes.

background: early in gestation maternal blood volume normally expands by an unknown mechanism; failure of this normal adaptation to pregnancy has been associated with common adverse pregnancy outcomes including preeclampsia, intrauterine growth retardation, and premature labor. the renin-angiotensin system has a critical role in controlling maternal fluid volume and probably in the pathophysiology of these serious complications of pregnancy. kenneth ward and his group have recently discovered dna variants which cause amino acid substitutions in angiotensinogen (renin substrate), one of which (t235) is strongly associated with preeclampsia. they hypothesize that functionally different angiotensinogen proteins may underlie the pathophysiology of preeclampsia and other related disorders (such as intrauterine growth retardation and premature labor) by not allowing normal volume expansion to occur. the four interrelated approaches in the study should lead to a better understanding of the role of angiotensinogen in pregnancy and of the pathophysiology of preeclampsia. unlike any previous finding in preeclamptic patients, the genetic alteration in angiotensinogen described is an intrinsic defect which, although it may be modified by other factors, cannot be 'secondary' to other pathophysiologic variables. this molecular hypothesis demands a reinterpretation of many prior findings in preeclampsia, fetal growth retardation, and premature labor based on angiotensinogen genotypes. the dna and plasma collected for this study will be invaluable resources for future molecular investigations of abnormal pregnancies. design narrative: four different strategies were used. first, a prospective, epidemiologic survey of 24,000 pregnancies was conducted to determine the role of the t235 variant in common disorders of pregnancy. from this population, nulligravida volunteers, 150 who were homozygous for t235 variant and 150 who were homozygous for the alternative m235 allele, were selected for a longitudinal study of maternal-fetal physiology and biochemistry in order to determine how and when the t235 variant exerted its adverse effect. taking advantage of the large average family size in utah, the female relatives of women with preeclampsia were also studied in order to define the genetics of important angiotensinogen variants. finally, dna from preeclamptic patients was examined for additional mutations in the angiotensinogen gene which may offer unique pathophysiologic insight. the study was renewed in 1999 for another four years to investigate the hypothesis that disease-associated angiotensinogen alleles promote abnormal spiral artery remodeling and inhibit maternal plasma volume expansion.

Eligibility criteria:
no eligibility criteria
wound closure after total knee arthroplasty: comparison of polypropylene and polyglactin 910 suture.

Conditions: Wound Heal; Wound Dehiscence; Wound Complication

Summary: comparison of wound complication and scar formation in patient undergone bilateral total knee replacement comparison between polypropylene and polyglactin 910 suture. patient randomised according to snos protocol into group a and b for their right and left knee closure with each suture. patient followed on 3rd, 7th, 15th and 30th post operative day for wound healing, wound dehiscence and scar formation.

all patients aged 50-80 years, belonging to either sex, diagnosed with end-stage osteoarthritis or post-traumatic arthritis, and scheduled for bilateral primary total knee arthroplasty at the department of orthopedics, indus hospital and health network, karachi were enrolled in the study. exclusion criteria included patients having existing skin, neuromuscular, or connective tissue disorders, rheumatoid arthritis, immunosuppression, morbid obesity, and pregnancy. all patients provided voluntary informed written consent before enrolment in the study. in all patients undergoing primary tka, one knee was closed using polypropylene, whereas the other was closed with polyglactin 910 sutures. all surgeries were performed by the same surgical team using a standard medial parapatellar approach. the number of sutures and wound closure techniques were standardized across both groups.

Eligibility criteria:
inclusion criteria: * age 50 to 80 years * both gender * inform consent * end stage osteoarthritis exclusion criteria: * age less the 50 and more then 80 * bmi more then 40 * rheumatoid arthritis * lack of consent * pregnant female
treatment for word retrieval impairments in aphasia

Conditions: Stroke

Summary: in this study the investigators are examining the effectiveness of two different speech therapy protocols for word retrieval impairments experienced by individuals with stroke-induced aphasia. one treatment involves errorless naming treatment and the other employs verbal plus gestural facilitation of word retrieval. participants will receive one of the two treatments over several months. before and after treatment the investigators will administer several tests and conversational samples to examine changes associated with the treatments. the investigators hypothesize that, whereas both treatments will lead to improvements in words rehearsed in therapy, communication outcomes in conversation will be broader for the verbal plus gestural protocol.

in this study the investigators are examining the effectiveness of two different speech therapy protocols for word retrieval impairments experienced by individuals with stroke-induced aphasia. one treatment involves errorless naming treatment and the other employs verbal plus gestural facilitation of word retrieval. participants will receive one of the two treatments over several months. before and after treatment the investigators will administer several tests and conversational samples to examine changes associated with the treatments. the investigators hypothesize that, whereas both treatments will lead to improvements in words rehearsed in therapy, communication outcomes in conversation will be broader for the verbal plus gestural protocol.

Eligibility criteria:
inclusion criteria: * left hemisphere stroke \>4 months earlier * aphasia with word retrieval impairments * \>21 years of age right handed * speaker of english as the preferred language * \>6 grade education exclusion criteria: * history of developmental learning difficulties * history of prior neurological illnesses * chronic medical illnesses that restrict participation in speech therapy * alcohol or drug dependence * severe uncorrected impairments of vision or hearing

Keywords: aphasia anomia speech therapy rehabilitation